Bioequivalence and Bioavailability Forum

Dear Osama,

❝ I think the risk of Mixing up is high when the PI and his/her clinical team are involved in both studies at the same time, think about adverse events which could be happened and his/her responsibility for the protection of study subjects, Mixing up in the collection of subjects study samples , ....etc

Not to mention ethical concerns, with the fasting subjects smelling the breakfast eaten by the fed subjects

More seriously: it really depends on how the CRO is set up. Many CROs have several, clearly separated clinics within the same building, which can operate totally independently. No difference from trials being run separately in time.

Having both trials being performed in the same room would indeed be at high risk, but not necessarily higher than having two trials on different drugs for different sponsors.

❝ ❝ In some countries the PI is purely an administrative matter; she or he will not see the subjects/patients but have everything delegated.

❝

❝ I know that in some very rare cases that the PI has purely an administrative job, but mostly he/she is a physician who do practically the clinical part from A to Z.

Again, in my experience it varies widely from one CRO to the next. Some CROs will appoint as principal investigator the most senior MD of the CRO, who will delegate most practical activities to sub-investigators.